ABSTRACT
Antibody drugs have become the first choice for clinical treatment of many diseases due to their advantages of targeting, high specificity and low toxicity. However, the disposal mechanism in vivo has its particularity and complexity, which greatly increases the difficulty of biological detection. Therefore, to establish the sensitive, accurate and repeatable methods is urgent. This paper mainly focuses on the bioanalytical methods of this kind of drugs, introduces the characteristics and application of enzyme-linked immunosorbent assay, electrochemiluminescence, liquid chromatography-mass spectrometry, flow cytometry and some new techniques, in hope of providing a reference for the study of related drugs.
ABSTRACT
Objective:To establish the bacterial endotoxin test method and the abnormal toxicity test method for reduced glutathi -one for injection.Methods:According to the requirements and methods in Chinese Pharmacopoeia (2015 edition, part IV), the bacte-rial endotoxin test and the abnormal toxicity test for reduced glutathione were studied .Results:The limit of bacterial endotoxin for re-duced glutathione was 0.125 EU· mg-1 , and the limit of abnormal toxicity was 1.0 g· kg-1 .Conclusion: The bacterial endotoxin test method and the abnormal toxicity test method are feasible .The abnormal toxicity should be supplemented in the quality standard for reduced glutathione , and the bacterial endotoxin test can replace the pyrogen test .